NCT02425046

Family Obesity Intervention: Motivational Interviewing and Community Support

Completed NA Results posted Last updated 5 February 2024

What this trial tests

NA trial testing health coaching in Obesity in 472 participants. Completed in 2 July 2020.

Timeline

26 March 2015

Primary endpoint
9 October 2018

2 July 2020

Quick facts

Lead sponsor	Helena Laroche
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	472
Start date	26 March 2015
Primary completion	9 October 2018
Estimated completion	2 July 2020
Sites	3 locations across United States

Drugs / interventions tested

• health coaching
• community screening

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Helena Laroche

Who can join

6 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Adult Body Mass Index Primary · Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months

Change in Adult BMI from baseline to 12 months

Group	Value	95% CI
Health Coaching and Community Screening	0.3	± 0.9
Community Screening	-0.1	± 0.7

Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity Primary · measured at baseline and 12 months - outcome is the change from baseline to 12 months.

Moderate to vigorous physical activity of the target adult measure by an accelerometer at baseline and 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.

Group	Value	95% CI
Health Coaching and Community Screening	-2.7	± 9.0
Community Screening	0.5	± 5.2

Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale Primary · measured at baseline and 12 months

Change in the Family Nutrition and Physical Activity Scale from baseline to 12 months - measure of behaviors relate to childhood obesity - parent reports for the target child. Scale scores possible range from 20 to 80. Higher indicates healthier behaviors.

Group	Value	95% CI
Health Coaching and Community Screening	2.2	± 0.9
Community Screening	2.8	± 1.0

Target Child - Change in Daily Moderate to Vigorous Physical Activity Primary · baseline and 12 months

Change in minutes per day of moderate to vigorous physical activity of the target child as measure by accelerometer from baseline to 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.

Group	Value	95% CI
Health Coaching and Community Screening	-7.0	± 3.0
Community Screening	-9.6	± 3.3

Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages Secondary · baseline and 12 months

Change in self-reported sugar-sweetened beverage intake per day from baseline to 12 months as reported by participant in numbers of 12 ounce cups or cans.

Group	Value	95% CI
Health Coaching and Community Screening	-0.6	± 0.4
Community Screening	-1.3	± 0.4

Adult - Physical Activity Questionnaires: Secondary · 12 month

Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day.

Group	Value	95% CI
Health Coaching and Community Screening	120	± 188
Community Screening	100	± 193

Adult - Waist Circumference: Secondary · 12 months

waist circumference in centimeters

Group	Value	95% CI
Health Coaching and Community Screening	114.3	± 13.8
Community Screening	119.7	± 14.9

Child - BMI Z-score: Secondary · 12 months

Change in child BMI z-score from baseline to 12 months. The BMI z-score (BMIz) indicates the number of standard deviations away from the mean BMI for age and sex as determined by the CDC growth curves. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Group	Value	95% CI
Health Coaching and Community Screening	0.0	± 0.04
Community Screening	0.0	± 0.0

Child - Screen Time Questionnaire: Secondary · 12 months

total hours of screen time per week as collected by questionnaire given to the parent

Group	Value	95% CI
Health Coaching and Community Screening	27	± 12.9
Community Screening	29	± 12.3

Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages Secondary · baseline and 12 months

Change in parent reported sugar-sweetened beverage intake per day from baseline to 12 months as reported per 12 ounce cup or can. Calculate by subtracting the baseline value from the 12 month value.

Group	Value	95% CI
Health Coaching and Community Screening	-0.5	± 0.2
Community Screening	-0.7	± 0.3

Sponsor's own description

Low-income children and children of obese parents are at high risk of obesity. Effective interventions are needed to target these families to improve the health of the parents and prevent obesity in the children. The hypothesis is that an intervention that combines engagement of community organizations, motivational interviewing (MI, a technique proven to help people set goals that are personally meaningful), and resource mobilization will change diet and physical activity habits among disadvantaged families. This proposal grew from an established community-based participatory research (CBPR) partnership between the research team and community organizations that serve high minority (45-55%), low-income populations. Partners include a community health center, a food pantry network, a work-force training program, and other agencies. These partners designed and implemented a successful pilot project on which this proposal is based. The specific aims of this proposal are 1) To evaluate the efficacy of a family-targeted obesity intervention based on MI and resource-mobilization. Hypotheses: In comparison to control families, families participating in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in minutes of moderate physical activity and decreased sedentary time for both adults and children accelerometer), and c) a reduction in the number of obesity risk behaviors and an increase in obesity prevention behaviors among children. 2) To examine the mediators of intervention effects. 3) Identify the types of resources needed most often by intervention families to support lifestyle change. This randomized controlled trial includes 260 low-income families that contain at least one obese adult and one normal or overweight child between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI to help families explore ambivalence toward and motivations for change and set goals for improving diet and physical activity. 2) To support goals, families will be connected with community agencies that can assist with general (e.g., financial) and goal specific resources (e.g., food, physical activity opportunities). Collaboration between organizations will streamline referrals, maximize resources, and facilitate access. Control families will get a basic screen for needs and information about available community resources. Outcomes are measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it 1) focuses on lifestyle changes for the entire family and measures outcomes in adults and children, 2) combines MI focused on the entire family and community resource referrals specific to family needs and goals for change, 3) partners community organizations to coordinate resources for families, and 4) involves partners in all research phases via a CBPR approach. This contribution will be significant because the proposed intervention, if successful, can be replicated elsewhere and adapted to the local resource environment to address adult obesity and prevent childhood obesity in a high-risk population. The study will also identify the types of resources low-income families need to change diet and physical activity.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to prevent obesity in children aged 5 to 11 years old.
   Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2
2. Family-Based Motivational Interviewing and Resource Mobilization to Prevent Obesity: Living Well Together Trial.
   Laroche HH, Andino J, O'Shea AMJ, Engebretsen B, et al · · 2024 · cited 3× · PMID 38904597 · DOI 10.1016/j.jneb.2024.05.227